COVID-19 Acute Respiratory Distress SyndromeURICOVNCT05699889
Acute Kidney Dysfunction in COVID-19 and Non-COVID-19 Related ARDS
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Acute Kidney Injury Due to COVID-19, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
In addition to respiratory involvement, SARS-CoV 2, the virus responsible for coronavirus 2019 or Covid-19, appears to be responsible for renal involvement such as acute renal failure or proteinuria, so the mechanisms are not known at this time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, Acute Kidney Injury Due to COVID-19
- What is being tested?
- Data collection
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment and Patients in intensive care without SARS-CoV 2 infection with severe respiratory impairment
Who may be able to join
- • Displaying acute respiratory distress Needing invasive mechanical ventilation
- With PaO2/FiO2 ratio < 300 after orotracheal intubation
Who cannot join
- Patients in ICU following thoracic surgery or lung transplantation
- Patients with cardiogenic pulmonary oedema
- Patients with end stage kidney disease
- Moribund patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of COVID-19-associated Kidney Injury in ICU and Prognosis of Proximal Tubular Injury in ARDS: the URICOV Study
In addition to respiratory involvement, SARS-CoV 2, the virus responsible for coronavirus 2019 or Covid-19, appears to be responsible for renal involvement such as acute renal failure or proteinuria, so the mechanisms are not known at this time. The consequences of Covid-19 on renal function in the short and long term are not known.
It is important to be able to better document these renal impairments to understand the mechanisms of this disease.
Read more
The main objective of this study is to describe the prevalence of Covid-19-related renal damage (acute renal failure, proteinuria, microalbuminuria, hematuria) in a large cohort of patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment.
The other objectives will be to evaluate in this cohort the impact of these renal impairments on the severity of the Covid-19 disease, and to compare them to the renal impairments of patients in intensive care for acute respiratory distress syndrome (ARDS) due to other respiratory diseases.
Blood and urine samples will be taken at the time of intubation in all critically ill patients with respiratory distress requiring mechanical ventilation for Covid-19 or other cause of respiratory distress with PaO2/FiO2 ratio < 300.
Patients will be followed for the duration of their ICU and hospital stay. Data will be collected prospectively in three ICUs in the University Hospitals of Marseille.
- Being tested
- Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
acute kidney injury and tubular dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment. | Not described Receives: Other: Data collection | |
| Patients in intensive care without SARS-CoV 2 infection with severe respiratory impairment. | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the incidence of acute kidney injury and tubular dysfunction
We aimed to perform a detailed analysis of urinary markers of kidney dysfunction with urine protein electrophoresis and tubular protein dosage in a prospective cohort of critically ill patients in ICU for ARDS due to COVID-19 in the first 24 hours following orotracheal intubation, to evaluate the incidence of acute kidney injury (AKI) and tubular dysfunction among critically ill patients with COVID-19-related ARDS at the onset of Mechanical ventilation, and to specify which part of the kidney parenchyma is involved.
Measured: First 24 hours after orotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start2 May 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie GARRIDO-PRADALIE, Study director, Assistance Publique Hopitaux De MarseilleMickaël BOBOT, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699889
- Sponsor's protocol ID
- RCAPHM20_0177
- Acronym
- URICOV
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of COVID-19-associated Kidney Injury in ICU and Prognosis of Proximal Tubular Injury in ARDS: the URICOV Study
- ClinicalTrials.gov ID
- NCT05699889
- Acronym / sponsor ID
- URICOV / RCAPHM20_0177
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In addition to respiratory involvement, SARS-CoV 2, the virus responsible for coronavirus 2019 or Covid-19, appears to be responsible for renal involvement such as acute renal failure or proteinuria, so the mechanisms are not known at this time. The consequences of Covid-19 on renal function in the short and long term are not known.
It is important to be able to better document these renal impairments to understand the mechanisms of this disease.
The main objective of this study is to describe the prevalence of Covid-19-related renal damage (acute renal failure, proteinuria, microalbuminuria, hematuria) in a large cohort of patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment.
The other objectives will be to evaluate in this cohort the impact of these renal impairments on the severity of the Covid-19 disease, and to compare them to the renal impairments of patients in intensive care for acute respiratory distress syndrome (ARDS) due to other respiratory diseases.
Blood and urine samples will be taken at the time of intubation in all critically ill patients with respiratory distress requiring mechanical ventilation for Covid-19 or other cause of respiratory distress with PaO2/FiO2 ratio < 300.
Patients will be followed for the duration of their ICU and hospital stay. Data will be collected prospectively in three ICUs in the University Hospitals of Marseille.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment. | – | Other: Data collection |
| Patients in intensive care without SARS-CoV 2 infection with severe respiratory impairment. | – | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment and Patients in intensive care without SARS-CoV 2 infection with severe respiratory impairment
Key inclusion criteria (2 listed)
- • Displaying acute respiratory distress Needing invasive mechanical ventilation
Key exclusion criteria (4 listed)
- Patients in ICU following thoracic surgery or lung transplantation
- Patients with cardiogenic pulmonary oedema
- Patients with end stage kidney disease
- Moribund patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionacute kidney injury and tubular dysfunction | Other | Patients in intensive care for SARS-CoV 2 infection with severe respiratory impairment., Patients in intensive care without SARS-CoV 2 infection with severe respiratory impairment. |
Primary outcome
Evaluation of the incidence of acute kidney injury and tubular dysfunction
Time frame: First 24 hours after orotracheal intubation
We aimed to perform a detailed analysis of urinary markers of kidney dysfunction with urine protein electrophoresis and tubular protein dosage in a prospective cohort of critically ill patients in ICU for ARDS due to COVID-19 in the first 24 hours following orotracheal intubation, to evaluate the incidence of acute kidney injury (AKI) and tubular dysfunction among critically ill patients with COVID-19-related ARDS at the onset of Mechanical ventilation, and to specify which part of the kidney parenchyma is involved.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie GARRIDO-PRADALIE study director
Assistance Publique Hopitaux De Marseille
Mickaël BOBOT principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Acute Kidney Injury Due to COVID-19, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the incidence of acute kidney injury and tubular dysfunction (time frame: First 24 hours after orotracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.